Back to resultsPrimary and Booster Vaccination Study With Pneumococcal Vaccine GSK1024850A in Healthy Japanese Children
Primary Purpose
Infections, Streptococcal
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Pneumococcal vaccine GSK1024850A
DTPa
Sponsored by
About this trial
This is an interventional prevention trial for Infections, Streptococcal focused on measuring Pneumococcal disease, Immunogenicity, Booster vaccination, Pneumococcal vaccine, Primary vaccination, Safety
Eligibility Criteria
Inclusion Criteria:
- Subjects who the investigator/co-investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR(s)) can and will comply with the requirements of the protocol.
- A male or female between, and including, 90 and 118 days of age (3 months) at the time of the first vaccination.
- Written informed consent obtained from the parent(s)/LAR(s) of the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- Born after a gestation period of 36 to 42 weeks inclusive.
Exclusion Criteria:
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of study vaccine(s), or planned use during the study period.
- Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
- Planned administration/administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before the first dose of study vaccine(s) and ending on the last study visit, with the exception of Haemophilus influenzae type b vaccine, Hepatitis B Vaccine, Bacille Calmette-Guérin vaccine, Oral Polio Vaccine, Japanese encephalitis, measles and rubella, varicella, mumps, and flu vaccines.
- Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
- Administration of any pneumococcal vaccine since birth except for the DTPa group for whom vaccination with a licensed pneumococcal vaccine by catch-up schedule will be allowed only if the 2 vaccine doses are administered between Study Visit 4 and 5, i.e. from the second blood sampling timepoint (Visit 4) onwards and up to 7 days before the booster dose of the DTPa vaccine.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
- History of, or intercurrent diphtheria, tetanus, pertussis disease.
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the study vaccines.
- Major congenital defects or serious chronic illness.
- History of any seizures or progressive neurological disease.
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
- Child in care.
- Acute disease and/or fever at the time of enrolment.
Sites / Locations
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
10Pn Group
DTPa Group
Arm Description
Healthy male or female subjects, between 90 and 118 days of age who received 3 doses of Synflorix (10Pn) vaccine, administered intramuscularly on alternating (left/right) sides of the anterolateral thigh and DPT "KAKETSUKEN" Syringe (DTPa) vaccine administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm. Both vaccines were administered at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age.
Healthy male or female subjects, between 90 and 118 days of age who received 3 doses of the DPT "KAKETSUKEN" Syringe (DTPa) vaccine, administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age.
Outcomes
Primary Outcome Measures
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Primary Immunization)
Concentrations were expressed as geometric mean concentrations (GMCs). Antibodies assessed for this outcome measure were those against the vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (ANTI-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 microgram per milliliter (µg/mL).
Secondary Outcome Measures
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Booster Immunization)
Antibodies assessed for this outcome measure were those against the vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (ANTI-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F). Antibody concentrations were measured by 22F ELISA, expressed as GMCs, in μg/mL. The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 μg/mL. Antibody concentrations < 0.05 μg/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.
Administration of catch-up pneumococcal vaccination with a licensed product other than Synflorix was allowed in the DTPa Group at least 7 days before DTPa vaccine booster dose. Thus, for this booster phase analysis, the DTPa Group was further split in DTPa + Prevenar Group and DTPa - no Prevenar Group.
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Primary Immunization)
Pneumococcal vaccine serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F and were calculated, expressed as geometric mean titers (GMTs). The seropositivity cut-off for the assay was ≥ 8. Antibody titers < 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation.
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Booster Immunization)
Pneumococcal vaccine serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F and were calculated, expressed as geometric mean titers (GMTs). The seropositivity cut-off for the assay was ≥ 8. Antibody titers < 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation. Administration of catch-up pneumococcal vaccination with a licensed product other than Synflorix was allowed in the DTPa Group at least 7 days before DTPa vaccine booster dose. Thus, for this booster phase analysis, the DTPa Group was further split in DTPa + Prevenar Group and DTPa - no Prevenar Group.
Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Primary Immunization)
Concentrations were given in microgram per millilitre (µg/mL) and were expressed in geometric mean antibody concentrations. Cross-reactive pneumococcal vaccine serotypes assessed were 6A and 19A. The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 µg/mL. Antibody concentrations < 0.05 µg/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.
Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Booster Immunization)
Concentrations were given in microgram per millilitre (µg/mL) and were expressed in geometric mean antibody concentrations. Cross-reactive pneumococcal vaccine serotypes assessed were 6A and 19A. The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 µg/mL. Antibody concentrations < 0.05 g/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation. Administration of catch-up pneumococcal vaccination with a licensed product other than Synflorix was allowed in the DTPa Group at least 7 days before DTPa vaccine booster dose. Thus, for this booster phase analysis, the DTPa Group was further split in DTPa + Prevenar Group and DTPa - no Prevenar Group.
Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Primary Immunization)
Cross-reactive pneumococcal vaccine serotypes assessed were 6A and 19A and were calculated, expressed as geometric mean titers (GMTs). The seropositivity cut-off for the assay was ≥ 8. Antibody titers < 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation.
Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Booster Immunization)
Cross-reactive pneumococcal vaccine serotypes assessed were 6A and 19A and were calculated, expressed as geometric mean titers (GMTs). The seropositivity cut-off for the assay was ≥ 8. Antibody titers < 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation. Administration of catch-up pneumococcal vaccination with a licensed product other than Synflorix was allowed in the DTPa Group at least 7 days before DTPa vaccine booster dose. Thus, for this booster phase analysis, the DTPa Group was further split in DTPa + Prevenar Group and DTPa - no Prevenar Group.
Concentrations of Antibodies Against Protein D (PD) (Primary Immunization)
Anti-protein D (Anti-PD) antibody concentrations by Enzyme-Linked Immunosorbent Assay (ELISA) were calculated, expressed as geometric mean concentrations (GMCs) in ELISA unit per milli-liter (EL.U/mL) and tabulated. The seropositivity cut-off for the assay was ≥ 100 EL.U/mL. Antibody concentrations < 100 EL.U/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.
Concentrations of Antibodies Against Protein D (PD) (Booster Immunization)
Anti-protein D (Anti-PD) antibody concentrations by Enzyme-Linked Immunosorbent Assay (ELISA) were calculated, expressed as geometric mean concentrations (GMCs) in ELISA unit per milli-liter (EL.U/mL) and tabulated. The seropositivity cut-off for the assay was ≥ 100 EL.U/mL. Antibody concentrations < 100 EL.U/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.
Concentrations of Antibodies Against Diphtheria Toxoid (DT) and Tetanus Toxoid (TT)(Primary Immunization)
Concentrations of antibodies are presented as geometric mean concentrations expressed as International units per millilitre (IU/mL). Seroprotection status, defined as Anti-DT or Anti-TT antibody concentration equal to or greater than 0.1 IU/mL.
Concentrations of Antibodies Against Diphtheria Toxoid (DT) and Tetanus Toxoid (TT)(Booster Immunization)
Concentrations of antibodies are presented as geometric mean concentrations expressed as International units per millilitre (IU/mL). Seroprotection status, defined as Anti-DT or Anti-TT antibody concentration equal to or greater than 0.1 IU/mL.
Concentrations of Antibodies Against Pertussis (PT) and Filamentous Haemagglutinin (FHA)(Primary Immunization)
Concentrations of antibodies are presented as geometric mean concentrations expressed as Enzyme-Linked Immuno-Sorbent Assay (ELISA) units per millilitre (EL.U/mL). Seropositivity was defined as an antibody concentration equal to or greater than 5 EL.U/mL
Concentrations of Antibodies Against Pertussis (PT) and Filamentous Haemagglutinin (FHA)(Booster Immunization)
Concentrations of antibodies are presented as geometric mean concentrations expressed as Enzyme-Linked Immuno-Sorbent Assay (ELISA) units per millilitre (EL.U/mL). Seropositivity was defined as an antibody concentration equal to or greater than 5 EL.U/mL
Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Primary Vaccination
Solicited local AEs assessed were pain, redness and swelling. Any = incidence of any local symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling above 30 millimetre.
Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Booster Vaccination
Solicited local AEs assessed were pain, redness and swelling. Any = incidence of any local symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling above 30 millimetre.
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Primary Vaccination
General AEs = drowsiness, fever (axillary ≥ 37.5 degrees Celsius), irritabilityand loss of appetite, vomiting. Any= Incidence of any symptom regardless of intensity grade or relationship to vaccination. Grade 3 drowsiness = prevented normal activity. Grade 3 irritability = crying that could not be comforted/ prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 3 fever = > 39.5°C Related = symptom assessed by the investigator as related to the vaccination.
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Booster Vaccination
Solicited general AEs = drowsiness, irritability, loss of appetite and fever (axillary ≥ 37.5 degrees Celsius). Any= Incidence of any symptom regardless of intensity grade or relationship to vaccination. Grade 3: drowsiness = prevented normal activity. irritability = crying that could not be comforted/ prevented normal activity. loss of appetite = not eating at all. Fever = temperature > 39.5°C Related = symptom assessed by the investigator as related to the vaccination.
Number of Subjects With Unsolicited AEs After Primary Vaccination
An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Number of Subjects With Unsolicited AEs After Booster Vaccination
An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Number of Subjects With Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01027845
Brief Title
Primary and Booster Vaccination Study With Pneumococcal Vaccine GSK1024850A in Healthy Japanese Children
Official Title
Immunogenicity, Safety and Reactogenicity of GlaxoSmithKline Biologicals' Pneumococcal Vaccine GSK1024850A Following Primary and Booster Vaccination of Healthy Japanese Children
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
December 8, 2009 (Actual)
Primary Completion Date
August 13, 2010 (Actual)
Study Completion Date
September 17, 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
5. Study Description
Brief Summary
This study will aim to evaluate the immunogenicity, safety and reactogenicity of GlaxoSmithKline Biologicals' 10-valent pneumococcal conjugate vaccine GSK1024850A when co-administered with Japanese DTPa vaccine as a 3-dose primary immunization course in healthy Japanese children at 3, 4 and 5 months of age and as a booster vaccination at 17-19 months of age.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infections, Streptococcal
Keywords
Pneumococcal disease, Immunogenicity, Booster vaccination, Pneumococcal vaccine, Primary vaccination, Safety
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
360 (Actual)
8. Arms, Groups, and Interventions
Arm Title
10Pn Group
Arm Type
Experimental
Arm Description
Healthy male or female subjects, between 90 and 118 days of age who received 3 doses of Synflorix (10Pn) vaccine, administered intramuscularly on alternating (left/right) sides of the anterolateral thigh and DPT "KAKETSUKEN" Syringe (DTPa) vaccine administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm. Both vaccines were administered at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age.
Arm Title
DTPa Group
Arm Type
Active Comparator
Arm Description
Healthy male or female subjects, between 90 and 118 days of age who received 3 doses of the DPT "KAKETSUKEN" Syringe (DTPa) vaccine, administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age.
Intervention Type
Biological
Intervention Name(s)
Pneumococcal vaccine GSK1024850A
Other Intervention Name(s)
Synflorix
Intervention Description
Intramuscular injection, 4 doses
Intervention Type
Biological
Intervention Name(s)
DTPa
Other Intervention Name(s)
DPT "KAKETSUKEN" Syringe
Intervention Description
Subcutaneous injection, 4 doses
Primary Outcome Measure Information:
Title
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Primary Immunization)
Description
Concentrations were expressed as geometric mean concentrations (GMCs). Antibodies assessed for this outcome measure were those against the vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (ANTI-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 microgram per milliliter (µg/mL).
Time Frame
1 month following primary immunization (at Month 3)
Secondary Outcome Measure Information:
Title
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Booster Immunization)
Description
Antibodies assessed for this outcome measure were those against the vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (ANTI-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F). Antibody concentrations were measured by 22F ELISA, expressed as GMCs, in μg/mL. The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 μg/mL. Antibody concentrations < 0.05 μg/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.
Administration of catch-up pneumococcal vaccination with a licensed product other than Synflorix was allowed in the DTPa Group at least 7 days before DTPa vaccine booster dose. Thus, for this booster phase analysis, the DTPa Group was further split in DTPa + Prevenar Group and DTPa - no Prevenar Group.
Time Frame
Prior to (PRE, at Month 14-16 ) and one month after booster (POST, at Month 15-17) immunization
Title
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Primary Immunization)
Description
Pneumococcal vaccine serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F and were calculated, expressed as geometric mean titers (GMTs). The seropositivity cut-off for the assay was ≥ 8. Antibody titers < 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation.
Time Frame
1 month following primary immunization (at Month 3)
Title
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Booster Immunization)
Description
Pneumococcal vaccine serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F and were calculated, expressed as geometric mean titers (GMTs). The seropositivity cut-off for the assay was ≥ 8. Antibody titers < 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation. Administration of catch-up pneumococcal vaccination with a licensed product other than Synflorix was allowed in the DTPa Group at least 7 days before DTPa vaccine booster dose. Thus, for this booster phase analysis, the DTPa Group was further split in DTPa + Prevenar Group and DTPa - no Prevenar Group.
Time Frame
Prior to (PRE, at Month 14-16) and one month after booster (POST, at Month 15-17) immunization
Title
Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Primary Immunization)
Description
Concentrations were given in microgram per millilitre (µg/mL) and were expressed in geometric mean antibody concentrations. Cross-reactive pneumococcal vaccine serotypes assessed were 6A and 19A. The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 µg/mL. Antibody concentrations < 0.05 µg/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.
Time Frame
1 month following primary immunization (at Month 3)
Title
Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Booster Immunization)
Description
Concentrations were given in microgram per millilitre (µg/mL) and were expressed in geometric mean antibody concentrations. Cross-reactive pneumococcal vaccine serotypes assessed were 6A and 19A. The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 µg/mL. Antibody concentrations < 0.05 g/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation. Administration of catch-up pneumococcal vaccination with a licensed product other than Synflorix was allowed in the DTPa Group at least 7 days before DTPa vaccine booster dose. Thus, for this booster phase analysis, the DTPa Group was further split in DTPa + Prevenar Group and DTPa - no Prevenar Group.
Time Frame
Prior to (PRE, at Month 14-16) and one month after booster (POST, at Month 15-17) immunization
Title
Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Primary Immunization)
Description
Cross-reactive pneumococcal vaccine serotypes assessed were 6A and 19A and were calculated, expressed as geometric mean titers (GMTs). The seropositivity cut-off for the assay was ≥ 8. Antibody titers < 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation.
Time Frame
1 month following primary immunization (at Month 3)
Title
Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Booster Immunization)
Description
Cross-reactive pneumococcal vaccine serotypes assessed were 6A and 19A and were calculated, expressed as geometric mean titers (GMTs). The seropositivity cut-off for the assay was ≥ 8. Antibody titers < 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation. Administration of catch-up pneumococcal vaccination with a licensed product other than Synflorix was allowed in the DTPa Group at least 7 days before DTPa vaccine booster dose. Thus, for this booster phase analysis, the DTPa Group was further split in DTPa + Prevenar Group and DTPa - no Prevenar Group.
Time Frame
Prior to (PRE, at Month 14-16) and one month after booster (POST, at Month 15-17) immunization
Title
Concentrations of Antibodies Against Protein D (PD) (Primary Immunization)
Description
Anti-protein D (Anti-PD) antibody concentrations by Enzyme-Linked Immunosorbent Assay (ELISA) were calculated, expressed as geometric mean concentrations (GMCs) in ELISA unit per milli-liter (EL.U/mL) and tabulated. The seropositivity cut-off for the assay was ≥ 100 EL.U/mL. Antibody concentrations < 100 EL.U/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.
Time Frame
1 month following primary immunization (at Month 3)
Title
Concentrations of Antibodies Against Protein D (PD) (Booster Immunization)
Description
Anti-protein D (Anti-PD) antibody concentrations by Enzyme-Linked Immunosorbent Assay (ELISA) were calculated, expressed as geometric mean concentrations (GMCs) in ELISA unit per milli-liter (EL.U/mL) and tabulated. The seropositivity cut-off for the assay was ≥ 100 EL.U/mL. Antibody concentrations < 100 EL.U/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.
Time Frame
Prior to (PRE, at Month 14-16) and one month after booster (POST, at Month 15-17) immunization
Title
Concentrations of Antibodies Against Diphtheria Toxoid (DT) and Tetanus Toxoid (TT)(Primary Immunization)
Description
Concentrations of antibodies are presented as geometric mean concentrations expressed as International units per millilitre (IU/mL). Seroprotection status, defined as Anti-DT or Anti-TT antibody concentration equal to or greater than 0.1 IU/mL.
Time Frame
1 month following primary immunization (at Month 3)
Title
Concentrations of Antibodies Against Diphtheria Toxoid (DT) and Tetanus Toxoid (TT)(Booster Immunization)
Description
Concentrations of antibodies are presented as geometric mean concentrations expressed as International units per millilitre (IU/mL). Seroprotection status, defined as Anti-DT or Anti-TT antibody concentration equal to or greater than 0.1 IU/mL.
Time Frame
Prior to (PRE, at Month 14-16) and one month after booster (POST, at Month 15-17) immunization
Title
Concentrations of Antibodies Against Pertussis (PT) and Filamentous Haemagglutinin (FHA)(Primary Immunization)
Description
Concentrations of antibodies are presented as geometric mean concentrations expressed as Enzyme-Linked Immuno-Sorbent Assay (ELISA) units per millilitre (EL.U/mL). Seropositivity was defined as an antibody concentration equal to or greater than 5 EL.U/mL
Time Frame
1 month following primary immunization (at Month 3)
Title
Concentrations of Antibodies Against Pertussis (PT) and Filamentous Haemagglutinin (FHA)(Booster Immunization)
Description
Concentrations of antibodies are presented as geometric mean concentrations expressed as Enzyme-Linked Immuno-Sorbent Assay (ELISA) units per millilitre (EL.U/mL). Seropositivity was defined as an antibody concentration equal to or greater than 5 EL.U/mL
Time Frame
Prior to (PRE, at Month 14-16) and one month after booster (POST, at Month 15-17) immunization
Title
Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Primary Vaccination
Description
Solicited local AEs assessed were pain, redness and swelling. Any = incidence of any local symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling above 30 millimetre.
Time Frame
During the 8-day (Days 0-7) after each primary vaccine dose
Title
Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Booster Vaccination
Description
Solicited local AEs assessed were pain, redness and swelling. Any = incidence of any local symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling above 30 millimetre.
Time Frame
During the 8-day (Days 0-7) period following booster vaccination
Title
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Primary Vaccination
Description
General AEs = drowsiness, fever (axillary ≥ 37.5 degrees Celsius), irritabilityand loss of appetite, vomiting. Any= Incidence of any symptom regardless of intensity grade or relationship to vaccination. Grade 3 drowsiness = prevented normal activity. Grade 3 irritability = crying that could not be comforted/ prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 3 fever = > 39.5°C Related = symptom assessed by the investigator as related to the vaccination.
Time Frame
During the 8-day (Days 0-7) after each primary vaccine dose
Title
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Booster Vaccination
Description
Solicited general AEs = drowsiness, irritability, loss of appetite and fever (axillary ≥ 37.5 degrees Celsius). Any= Incidence of any symptom regardless of intensity grade or relationship to vaccination. Grade 3: drowsiness = prevented normal activity. irritability = crying that could not be comforted/ prevented normal activity. loss of appetite = not eating at all. Fever = temperature > 39.5°C Related = symptom assessed by the investigator as related to the vaccination.
Time Frame
During the 8-day (Days 0-7) period following booster vaccination
Title
Number of Subjects With Unsolicited AEs After Primary Vaccination
Description
An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Time Frame
Within the 31-day (Days 0-30) post-primary vaccination period, across doses
Title
Number of Subjects With Unsolicited AEs After Booster Vaccination
Description
An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Time Frame
Within the 31-day (Days 0-30) post booster vaccination period
Title
Number of Subjects With Serious Adverse Events (SAEs)
Description
SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.
Time Frame
From study start at Month 0 up to study end at Month 15-17
10. Eligibility
Sex
All
Minimum Age & Unit of Time
90 Days
Maximum Age & Unit of Time
118 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Subjects who the investigator/co-investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR(s)) can and will comply with the requirements of the protocol.
A male or female between, and including, 90 and 118 days of age (3 months) at the time of the first vaccination.
Written informed consent obtained from the parent(s)/LAR(s) of the subject.
Healthy subjects as established by medical history and clinical examination before entering into the study.
Born after a gestation period of 36 to 42 weeks inclusive.
Exclusion Criteria:
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of study vaccine(s), or planned use during the study period.
Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
Planned administration/administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before the first dose of study vaccine(s) and ending on the last study visit, with the exception of Haemophilus influenzae type b vaccine, Hepatitis B Vaccine, Bacille Calmette-Guérin vaccine, Oral Polio Vaccine, Japanese encephalitis, measles and rubella, varicella, mumps, and flu vaccines.
Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
Administration of any pneumococcal vaccine since birth except for the DTPa group for whom vaccination with a licensed pneumococcal vaccine by catch-up schedule will be allowed only if the 2 vaccine doses are administered between Study Visit 4 and 5, i.e. from the second blood sampling timepoint (Visit 4) onwards and up to 7 days before the booster dose of the DTPa vaccine.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
History of, or intercurrent diphtheria, tetanus, pertussis disease.
History of any reaction or hypersensitivity likely to be exacerbated by any component of the study vaccines.
Major congenital defects or serious chronic illness.
History of any seizures or progressive neurological disease.
Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
Child in care.
Acute disease and/or fever at the time of enrolment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Aichi
ZIP/Postal Code
451-0052
Country
Japan
Facility Name
GSK Investigational Site
City
Chiba
ZIP/Postal Code
299-4503
Country
Japan
Facility Name
GSK Investigational Site
City
Hiroshima
ZIP/Postal Code
720-8520
Country
Japan
Facility Name
GSK Investigational Site
City
Hiroshima
ZIP/Postal Code
730-8562
Country
Japan
Facility Name
GSK Investigational Site
City
Hokkaido
ZIP/Postal Code
003-0021
Country
Japan
Facility Name
GSK Investigational Site
City
Kagawa
ZIP/Postal Code
765-8501
Country
Japan
Facility Name
GSK Investigational Site
City
Kanagawa
ZIP/Postal Code
238-8567
Country
Japan
Facility Name
GSK Investigational Site
City
Kanagawa
ZIP/Postal Code
243-8551
Country
Japan
Facility Name
GSK Investigational Site
City
Kanagawa
ZIP/Postal Code
247-8533
Country
Japan
Facility Name
GSK Investigational Site
City
Nagasaki
ZIP/Postal Code
856-8562
Country
Japan
Facility Name
GSK Investigational Site
City
Niigata
ZIP/Postal Code
957-8588
Country
Japan
Facility Name
GSK Investigational Site
City
Okayama
ZIP/Postal Code
701-0205
Country
Japan
Facility Name
GSK Investigational Site
City
Osaka
ZIP/Postal Code
555-0001
Country
Japan
Facility Name
GSK Investigational Site
City
Osaka
ZIP/Postal Code
560-0004
Country
Japan
Facility Name
GSK Investigational Site
City
Osaka
ZIP/Postal Code
591-8025
Country
Japan
Facility Name
GSK Investigational Site
City
Tokyo
ZIP/Postal Code
152-0021
Country
Japan
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
IPD for this study is available via the Clinical Study Data Request site (click on the link provided below)
IPD Sharing Time Frame
IPD is available via the Clinical Study Data Request site (click on the link provided below)
IPD Sharing Access Criteria
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months
IPD Sharing URL
https://www.clinicalstudydatarequest.com/Posting.aspx?ID=2812
Citations:
PubMed Identifier
25830489
Citation
Iwata S, Kawamura N, Kuroki H, Tokoeda Y, Miyazu M, Iwai A, Oishi T, Sato T, Suyama A, Francois N, Shafi F, Ruiz-Guinazu J, Borys D. Immunogenicity and safety of the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) co-administered with DTPa vaccine in Japanese children: A randomized, controlled study. Hum Vaccin Immunother. 2015;11(4):826-37. doi: 10.1080/21645515.2015.1012019.
Results Reference
background
Links:
URL
https://www.clinicalstudydatarequest.com
Description
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Available IPD and Supporting Information:
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
112640
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
112640
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Dataset Specification
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
112640
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Statistical Analysis Plan
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
112640
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
112640
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Informed Consent Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
112640
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Learn more about this trial
Primary and Booster Vaccination Study With Pneumococcal Vaccine GSK1024850A in Healthy Japanese Children
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